Kornimate/medical-research-clean huggingface dataset:
a clinical trial of nebulized surfactant for the treatment of moderate to severe covid-19

Conditions: Respiratory Infections

Summary: lung surfactant is present in the lungs. it covers the alveolar surface where it reduces the work of breathing and prevents the lungs from collapsing. in some respiratory diseases and in patients that require ventilation this substance does not function normally. this study will introduce surfactant to the patients lungs via the covsurf drug delivery system

the hypothesis behind the proposed trial of surfactant therapy for covid-19 infected patients requiring ventilator support is that endogenous surfactant is dysfunctional. this could be due to decreased concentration of surfactant phospholipid and protein, altered surfactant phospholipid composition, surfactant protein proteolysis and/or oedema protein inhibition of surfactant surface tension function and/or oxidative inactivation of surfactant proteins. variations of these dysfunctional mechanisms have been reported in a range of lung diseases, including cystic fibrosis and severe asthma, and in child and adult patients with ards. our studies of surfactant metabolism in adult ards patients showed altered percentage composition of surfactant pc, with decreased dppc and increased surface tension-inactive unsaturated species, and decreased concentrations of both total pc and phosphatidylglycerol (pg) the sars-cov-2 virus binds to the angiotensin converting enzyme-2 (ace2) receptor, which is preferentially expressed in the peripheral lung atii cells. consequent viral infection of atii cells could reduce cell number and impair the capacity of the lungs to synthesise and secrete surfactant. this, however, has not yet been demonstrated empirically in covid-19 patients. if this is the case, then exogenous surfactant administration to the lungs is potential one treatment option to mitigate disease severity in these patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * confirmed covid-19 positive by pcr * within 24 hours of mechanical ventilation (eti arm) or within 24 hours of needing either cpap or niv (cpap/niv arm) * assent or professional assent obtained exclusion criteria: * imminent expected death within 24 hours * specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage) * known or suspected pregnancy * stage 4 severe chronic kidney disease or requiring dialysis (i.e., egfr \< 30) * liver failure * anticipated transfer to another hospital, which is not a study site within 72 hours. * current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes. * consent declined
ace-inhibitors in extracapillary glomerulonephritis

Conditions: Extracapillary Glomerulonephritis

Summary: the natural course of extracapillary glomerulonephritis is severe leading to end-stage renal disease (esrd) or death in most cases. despite immunosuppressive treatment, long-term renal outcome remains poor since active crescents usually progress to fibrotic scars with glomerular occlusion and disruption.in experimental models angiotensin converting enzyme (ace)-inhibitor therapy targeting the over-expression of angiotensin type 1 (at1) receptors, that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the formation of crescents and their fibrotic evolution. should these drugs have similar effects in humans, ace-inhibitor therapy on top of standard immunosuppression might be instrumental to prevent esrd and promote renal function recovery in clinical practice.


Eligibility criteria:
inclusion criteria: * rapidly progressive renal failure associated with acute nephritic syndrome and/or nephrotic syndrome; * histology evidence of extracapillary proliferation with less than 50% of sclerotic glomeruli and associated with: 1. type i: anti-glomerular basement membrane (gbm) antibody glomerulonephritis, 2. type ii: pauci-immune vasculitis or anti neutrophil cytoplasmic antibody (anca) associated vasculitis; 3. type iii: immune-complex mediated glomerular diseases: proliferative lupus nephritis (ln), iga nephropathy (igan)/ schönlein-henoch purpura, type i membranoproliferative glomerulonephropathy (mpgn), primary or secondary membranous nephropathy (mn), primary or idiopathic immune complex glomerulonephritis. * clinical indication to immunosuppressive therapy; * no specific indication to treatment with renin angiotensin system (ras) inhibitors such as heart failure or coronary ischemic disease; * written informed consent. exclusion criteria: * pre-existing advanced chronic renal failure (creatinine clearance less than 20 ml/min/1.73m2); * evidence of b or c virus active infection; * hiv infection; * recent diagnosis of malignancy; * prolonged bleeding time and any other contraindication to kidney biopsy evaluation; * any specific contraindication to ace inhibitor therapy (that is: history of angioedema or other treatment-related serious adverse events); * pregnancy or lactating; * women of childbearing potential without following a scientifically accepted form of contraception; * inability to understand the risks and benefit of the study or evidence of an uncooperative attitude; * legal incapacity.

Keywords: extracapillary glomerulonephritis crescentic glomerulonephritis rapidly progressive renal failure chronic kidney disease ace-inhibitors fibrosis
renal function after stentgraft treatment of abdominal aortic aneurysm

Conditions: Aortic Aneurysm, Abdominal; Renal Insufficiency; Stent-Graft Thrombosis

Summary: this randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (aaa) with stentgrafts either with active supra- or infrarenal fixation.

this randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm with stentgrafts either with active supra- or infrarenal fixation. individuals are planned to be included throughout scandinavia. after inclusion in the study, baseline data is collected and computerized randomization between the two stent graft fixation types is performed. follow-up will be scheduled after 1 month and 1,3 and 5 years. analyses of blood samples to determine renal function are undertaken together with ct scans to detect stentgraft performance at all follow-up visits alongside assessments of health-related quality of life questionnaires.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * meet criteria for non-ruptured infrarenal/iliac aneurysm * suitable anatomy for treatment with an approved device (ce-marked) stentgraft according to the manufacturers' instructions for use for aaa. * accepted for treatment with endovascular aortic repair (evar) by the participating vascular center. exclusion criteria: * ongoing or planned dialysis * aaa treatment requiring stents or stentgrafts in renal and/or visceral arteries * inability to independently complete hrqol questionnaires due to language barriers * anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (\>60 degrees), advanced suprarenal dilatation or infrarenal thrombus \>25% of circumference.

Keywords: abdominal aortic aneurysm postoperative renal failure stentgraft complication
hemodynamic effects of negative pressure ventilation in chronic obstructive pulmonary disease

Conditions: COPD

Summary: negative pressure ventilation (npv) is a non-invasive ventilation mode which provide better lung expansion. the major complication of npv is decrease blood pressure and affects the hemodynamics. the effects of npv on chronic obstructive pulmonary disease (copd) patients with pulmonary rehabilitation program remains unknown.

both of npv or positive pressure ventilation (ppv) has impact of hemodynamics. npv with cuirass ventilator increases venous return and leads to ventricular filling and increases cardiac output (co); in contrast to npv, the effect of ppv in most situations is a decreased venous return and leads to decreased co. npv improving ventilation and work of breathing in patients with chronic obstructive pulmonary disease (copd).

Eligibility criteria:
inclusion criteria: * patients with copd who received pulmonary rehabilitation program with npv treatment exclusion criteria: * recent exacerbation within 3-months * existing of tracheostomy * absence of npv used * required of oxygen supplement during npv * diagnosed of neuromuscular disease
use of nutraceuticals in clinical practice

Conditions: Dyslipidemias; Diabetes Mellitus, Type 2; Hypertension

Summary: the aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a mediterranean diet scheme, normally recommended in the clinic. in particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.

the aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a mediterranean diet scheme, normally recommended in the clinic. in particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. in particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), l-arginine (250 mg/day).

Eligibility criteria:
inclusion criteria: diabetic patients in primary and secondary prevention or hypertensive patients in primary and secondary prevention or dyslipidemic patients in primary and secondary prevention exclusion criteria: patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
the value of dual-parametric magnetic resonance combined with regional saturation biopsy in patients with suspected prostate cancer

Conditions: Prostate Cancer

Summary: the aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpmri) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study. the main questions it aims to answer are: can bpmri guide the timing of prostate puncture and avoid unnecessary prostate biopsy? effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.


Eligibility criteria:
inclusion criteria: 1. be 18 years of age or older. 2. compliance with clinical guidelines for indications for prostate puncture: * suspicious prostate nodule detected on rectal palpation; * suspicious lesion detected by transrectal ultrasound or magnetic resonance; * tpsa \> 10 ng/ml; * tpsa 4-10 ng/ml with f/t \ 0.15. 3. complete sequence of bpmri of the prostate at our institution; exclusion criteria: 1. tpsa \>50ng/ml; 2. presence of contraindications to prostate puncture and inability to tolerate prostate puncture; 3. reatment with radiotherapy, chemotherapy and surgery before prostate puncture; 4. history of prostate cancer; 5. prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.
solfamu study of nasal brushing collected olfactory mucosa samples in the diagnosis of human encephalopathies

Conditions: Encephalopathy; HIV-encephalopathy; Alzheimer Dementia

Summary: encephalopathies are a group of central nervous system (cns) affection with heterogeneous etiology. several causes have been recognized including neurodegenerative, vascular, infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders. while 30-50% of acute encephalitis remains without etiological definition, definitive criteria for neurodegenerative diseases are usually unavailable in vivo and possible or probable definitions are used. the olfactory mucosa (om) is the part of the nasal mucosa that carries the specialized sensory organ for the modality of smell; the olfactory epithelium is composed of five principal cell types including olfactory receptor neurons. a sample of om may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients, not-contraindicated in patients with raised intracranial pressure and associated with almost no side-effects. nasal brushing has recently been proposed for the in vivo diagnosis of creutzfeldt-jakob disease (cjd). aims of the project are: 1. training of ear throat and nose (etn), infectious disease (id) and neurology (neu) specialists in the technique of nasal brushing; 2. conducting a prospective study comparing the use of nasal brushing with gold-standard criteria in the diagnosis of encephalopathies; 3. increasing the diagnostic and prognostic power in the diagnosis of encephalopathies. a prospective, case control, multicentric study enrolling 400 patients and 100 controls (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). patients will be diagnosed and followed according to international guidelines and local clinical practice. cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the diagnosis according to the clinical or radiological suspect.


Eligibility criteria:
inclusion criteria for cases: * age\>18 years; * signing a written informed consent (by the patients or his/her legal representant); * clinical suspect of encephalopathy (acute or subacute) including acute encephalitis, neurodegenerative disorders and hiv-associated neurocognitive disorders. inclusion criteria for controls: * age\>18 years; * signing a written informed consent (by the patients or his/her legal representant); • clinical indication for rhinoscopy for stenotic disease of nasal sept or turbinates. exclusion criteria: * nasal anatomical abnormalities precluding the execution of nasal brushing; * serious general conditions and/or comorbidities in patients for whom nasal brushing may be a risk factor precipitating their pre-existing condition; * anti-coagulant treatment.
national snapshot study adhesive small bowel obstruction (asbo)

Conditions: Surgery-Induced Tissue Adhesion; Surgical Adhesions; Adhesion, Tissue

Summary: over 63-90% of patients develop peritoneal adhesions after abdominal or pelvic surgery. which makes it the most common complication after abdominal or pelvic surgery. adhesions comprise a lifelong risk of adhesion related complications.the most frequent emergency complication of adhesion is an episode of adhesive small bowel obstruction (asbo). over 1 in 5 patients experiences at least 1 episode of asbo in the 10 years following initial abdominal surgery. despite the high incidence of asbo, diagnosis and treatment of an episode of asbo varies greatly between hospitals and even between doctors. until now, optimal treatment patterns are unknown. the aim of this study is mapping of care for patients with a suspected episode of asbo. with the collected data new hypothesis will be generated for the ideal diagnostic and therapeutic workflow for patients with a suspicion of an episode of asbo.


Eligibility criteria:
inclusion criteria: * suspicion asbo * age 18 years or older exclusion criteria: * clear other cause of small bowel obstruction (e.g. tumor, hernia)
correlation, accuracy, precision and practicability of zero heat flux temperature monitoring

Conditions: Hypothermia

Summary: hypothermia is common in patients undergoing general anesthesia. there have been several negative outcomes reported. zero heat flux is a non-invasive method for measurement of body core temperature. the aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.

hypothermia is common in patients undergoing general anesthesia. there have been several negative outcomes reported such as bleeding, infection rate, cardiac complications, prolonged wound healing and patient discomfort. zero heat flux is a non-invasive method for measurement of body core temperature. the aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring. measurements are performed with the spoton® sensor by arizant healthcare, inc..

Eligibility criteria:
inclusion criteria: * elective surgery in gynecology or trauma surgery * planned surgery time \> 60 min * patients older than 16 years exclusion criteria: * emergency surgery * need for post-surgery ventilation * patient's denial to take part in the study

Keywords: perioperative hypothermia zero heat flux non-invasive measurement of body core temperature
a clinical trial study to evaluate the pharmacokinetic interaction and safety between br1019-1 and br1019-2 in healthy adult subjects

Conditions: Hypertension; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the pharmacokinetic interaction and safety between br1019-1 and br1019-2 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy adults aged 19 to 55 years at screening * those who voluntarily decide to participate in the study and provide written consent to follow the study directions after listening to and fully understanding the detailed explanation on this study exclusion criteria: * those who have clinically significant diseases associated with the cardiovascular system, respiratory system, liver, kidney, nervous system, endocrine system, blood/tumor, psychiatric disorders, or urinary system, as well as drug abuse, or a history thereof. * those who took any prescription drugs or herbal medicines within 14 days prior to the first day of administration or any over-the-counter (otc) drugs within 7 days prior to the first day of administration (however, if other conditions are appropriate according to the judgment of the investigator, they may participate in the clinical study.) * those who took drugs inducing and inhibiting drug-metabolizing enzymes, such as barbiturates, within 30 days prior to the study initiation. * those who have been on a diet (especially grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 7 days prior to the first day of administration. * pregnant women, potentially pregnant women, or breast-feeding women those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically acceptable methods of contraception\* throughout the entire period from the date of the first administration of the investigational product to the end of the clinical study * medically acceptable methods of contraception: combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used * those who are unwilling or unable to comply with the dietary and lifestyle guidelines required for the clinical study * those who have clinically significant abnormalities in the results of other clinical laboratory tests or who have been determined by the investigator to be ineligible to participate in the clinical study due to other reasons (e.g., non-compliance with instructions, uncooperative attitude, etc.)
assessment of the effects of maela connected follow-up on well-being and pain after lumbar spine surgery

Conditions: Lumbar Spine Surgery; Quality of Life; Pain

Summary: digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. no study has investigated the effects of connected follow-up on lumbar spine inpatients. the purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.


Eligibility criteria:
inclusion criteria: * first ever lumbar spine surgery in the context of a degenerative spinal pathology * age between 18 and 60 yo * providing free and informed consent to participate * having a smartphone able to process maela application

Keywords: mobile app follow-up lumbar spine surgery quality of life pain
exosomes in rectal cancer

Conditions: Rectal Cancer

Summary: the primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of apr or lar. the researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.

all male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 fu or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 gy in 28 fractions. radiation treatments will be administered daily, monday thru friday. within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. a final serum sample will be collected within one month after definitive surgery. each serum sample collected will be less than 50 ml. the study will involve obtaining serum samples from patients before during and after chemoradiation therapy. these serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record. additional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports.

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 and older * histologically proven diagnosis of rectal adenocarcinoma * will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection exclusion criteria: * age less than 18. * patients who are unable or unwilling to undergo definitive surgery. * patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy. * patients with a prior history of cancer (excluding non-melanoma skin cancers). * patients who are immunocompromised.

Keywords: neoadjuvant chemoradiation therapy low anterior resection abdominoperineal resection exosomes biomarkers external beam radiation
optimal pharmacological therapy in implantable defibrillator patients (optic)

Conditions: Ventricular Tachycardia

Summary: this is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of icd shocks in patients receiving an icd for spontaneous or inducible ventricular tachycardia or fibrillation


Eligibility criteria:
inclusion criteria: spontaneous or inducible ventricular tachycardia or fibrillation - exclusion criteria: -